Blood Loss, Surgical Clinical Trial
— HYPALBOfficial title:
Impact of Hyperoncotic Albumin to Support Blood Loss Replacement on Plasma Volume Expansion in Cystectomy Patients.
Verified date | February 2020 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Fluid treatment is usually performed with either balanced crystalloid fluids or iso-oncotic
colloids, (synthetic colloids, plasma and 5% albumin). Doubts have been raised about
synthetic colloids (impairment of renal function and coagulation), and the natural albumin
has been used more extensively. Albumin is the main protein responsible for plasma oncotic
pressure and its volume expansion effect. An alternative therapeutic option is the
mobilization of tissue fluid by infusing a small amount of hyper-oncotic fluid like the 20%
albumin solution (endogenous fluid recruitment).
The primary objective of this study is to test the effect of 20% albumin on plasma volume
expansion and fluid recruitment in the frame of blood loss replacement during cystectomy
using established fluid kinetic models.
The investigators expect that fluid replacement with crystalloid will be better sustained
intravascularly with the administration of 20% albumin and be able to recruit fluid into the
vascular compartment.
Status | Completed |
Enrollment | 24 |
Est. completion date | February 18, 2020 |
Est. primary completion date | February 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Non emergent radical cystectomy with urinary diversion - Adult: older than 18 years - Written informed consent Exclusion Criteria: - Significant renal dysfunction: glomerular filtration rate < 60 ml/min/1,73 m² (Kidney Disease Outcomes Quality Initiative stage 3 or more ) - History of heart failure - Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product, - Women who are pregnant or breast feeding (exclusion of surgery per se) - Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, - Enrolment of the investigator, his/her family members, employees and other dependent persons |
Country | Name | City | State |
---|---|---|---|
Switzerland | Patrick Wuethrich, Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern | Bern | BE |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma volume expansion | Calculated by kinetics models | 5 hours | |
Secondary | Colloid osmotic pressure | Measured by oncometer | 5 hours | |
Secondary | Fluid balance | Composite score calculated according to fluid administered (crystalloid, colloids, blood products) and fluid loss (urine and blood) | 24 hours | |
Secondary | Complications rate | Assessment of all complications occurring from postoperative day 1 to 90 according to the Clavien Dindo classification | 90 days |
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